Zegalogue

ZEGALOGUE

^® is indicated for the treatment of severe hypoglycemia in pediatric and adult patients with diabetes aged 6 years and above.

• ZEGALOGUE autoinjector and prefilled syringe are for subcutaneous injection only. (
  
  
  
  2.1 Administration Instructions

  ZEGALOGUE autoinjector and prefilled syringe are for subcutaneous injection only.

  Instruct patients and their caregivers on the signs and symptoms of severe hypoglycemia. Because severe hypoglycemia requires the help of others to recover, instruct the patient to inform those around them about ZEGALOGUE and its Instructions For Use. Administer ZEGALOGUE as soon as possible when severe hypoglycemia is recognized.

  Instruct the patient or caregiver to read the Instructions For Use at the time they receive a prescription for ZEGALOGUE. Emphasize the following instructions to the patient or caregiver:

  • Administer ZEGALOGUE according to the printed instructions on the protective case label and the Instructions For Use.
  • Visually inspect ZEGALOGUE prior to administration. The solution should appear clear, colorless, and free from particles. If the solution is discolored or contains particulate matter, do not use.
  • Administer the injection in the lower abdomen, buttocks, thigh, or outer upper arm.
  • Call for emergency assistance immediately after administering the dose.
  • If there has been no response after 15 minutes, an additional dose of ZEGALOGUE may be administered while waiting for emergency assistance.
  • When the patient has responded to treatment, give oral carbohydrates to restore liver glycogen and prevent recurrence of hypoglycemia.
  • Do not attempt to reuse ZEGALOGUE. Each ZEGALOGUE device contains a single dose of dasiglucagon and cannot be reused.
  )
  
  
• The dose in adults and pediatric patients aged 6 years and older is 0.6 mg. (
  
  
  
  2.2 Recommended Dosage

  The recommended dose of ZEGALOGUE in adults and pediatric patients aged 6 years and older is 0.6 mg administered by subcutaneous injection into the lower abdomen, buttocks, thigh, or outer upper arm.

  If there has been no response after 15 minutes, an additional 0.6 mg dose of ZEGALOGUE from a new device may be administered.
  )
  
  
• Administer ZEGALOGUE according to the printed instructions on the protective case label and the Instructions For Use. (
  
  
  
  2.1 Administration Instructions

  ZEGALOGUE autoinjector and prefilled syringe are for subcutaneous injection only.

  Instruct patients and their caregivers on the signs and symptoms of severe hypoglycemia. Because severe hypoglycemia requires the help of others to recover, instruct the patient to inform those around them about ZEGALOGUE and its Instructions For Use. Administer ZEGALOGUE as soon as possible when severe hypoglycemia is recognized.

  Instruct the patient or caregiver to read the Instructions For Use at the time they receive a prescription for ZEGALOGUE. Emphasize the following instructions to the patient or caregiver:

  • Administer ZEGALOGUE according to the printed instructions on the protective case label and the Instructions For Use.
  • Visually inspect ZEGALOGUE prior to administration. The solution should appear clear, colorless, and free from particles. If the solution is discolored or contains particulate matter, do not use.
  • Administer the injection in the lower abdomen, buttocks, thigh, or outer upper arm.
  • Call for emergency assistance immediately after administering the dose.
  • If there has been no response after 15 minutes, an additional dose of ZEGALOGUE may be administered while waiting for emergency assistance.
  • When the patient has responded to treatment, give oral carbohydrates to restore liver glycogen and prevent recurrence of hypoglycemia.
  • Do not attempt to reuse ZEGALOGUE. Each ZEGALOGUE device contains a single dose of dasiglucagon and cannot be reused.
  )
  
  
• Visually inspect ZEGALOGUE prior to administration. The solution should appear clear, colorless, and free from particles. If the solution is discolored or contains particulate matter, do not use. (
  
  
  
  2.1 Administration Instructions

  ZEGALOGUE autoinjector and prefilled syringe are for subcutaneous injection only.

  Instruct patients and their caregivers on the signs and symptoms of severe hypoglycemia. Because severe hypoglycemia requires the help of others to recover, instruct the patient to inform those around them about ZEGALOGUE and its Instructions For Use. Administer ZEGALOGUE as soon as possible when severe hypoglycemia is recognized.

  Instruct the patient or caregiver to read the Instructions For Use at the time they receive a prescription for ZEGALOGUE. Emphasize the following instructions to the patient or caregiver:

  • Administer ZEGALOGUE according to the printed instructions on the protective case label and the Instructions For Use.
  • Visually inspect ZEGALOGUE prior to administration. The solution should appear clear, colorless, and free from particles. If the solution is discolored or contains particulate matter, do not use.
  • Administer the injection in the lower abdomen, buttocks, thigh, or outer upper arm.
  • Call for emergency assistance immediately after administering the dose.
  • If there has been no response after 15 minutes, an additional dose of ZEGALOGUE may be administered while waiting for emergency assistance.
  • When the patient has responded to treatment, give oral carbohydrates to restore liver glycogen and prevent recurrence of hypoglycemia.
  • Do not attempt to reuse ZEGALOGUE. Each ZEGALOGUE device contains a single dose of dasiglucagon and cannot be reused.
  )
  
  
• Administer the injection into the lower abdomen, buttocks, thigh, or outer upper arm. (
  
  
  
  2.1 Administration Instructions

  ZEGALOGUE autoinjector and prefilled syringe are for subcutaneous injection only.

  Instruct patients and their caregivers on the signs and symptoms of severe hypoglycemia. Because severe hypoglycemia requires the help of others to recover, instruct the patient to inform those around them about ZEGALOGUE and its Instructions For Use. Administer ZEGALOGUE as soon as possible when severe hypoglycemia is recognized.

  Instruct the patient or caregiver to read the Instructions For Use at the time they receive a prescription for ZEGALOGUE. Emphasize the following instructions to the patient or caregiver:

  • Administer ZEGALOGUE according to the printed instructions on the protective case label and the Instructions For Use.
  • Visually inspect ZEGALOGUE prior to administration. The solution should appear clear, colorless, and free from particles. If the solution is discolored or contains particulate matter, do not use.
  • Administer the injection in the lower abdomen, buttocks, thigh, or outer upper arm.
  • Call for emergency assistance immediately after administering the dose.
  • If there has been no response after 15 minutes, an additional dose of ZEGALOGUE may be administered while waiting for emergency assistance.
  • When the patient has responded to treatment, give oral carbohydrates to restore liver glycogen and prevent recurrence of hypoglycemia.
  • Do not attempt to reuse ZEGALOGUE. Each ZEGALOGUE device contains a single dose of dasiglucagon and cannot be reused.
  )
  
  
• Call for emergency assistance immediately after administering the dose. (
  
  
  
  2.1 Administration Instructions

  ZEGALOGUE autoinjector and prefilled syringe are for subcutaneous injection only.

  Instruct patients and their caregivers on the signs and symptoms of severe hypoglycemia. Because severe hypoglycemia requires the help of others to recover, instruct the patient to inform those around them about ZEGALOGUE and its Instructions For Use. Administer ZEGALOGUE as soon as possible when severe hypoglycemia is recognized.

  Instruct the patient or caregiver to read the Instructions For Use at the time they receive a prescription for ZEGALOGUE. Emphasize the following instructions to the patient or caregiver:

  • Administer ZEGALOGUE according to the printed instructions on the protective case label and the Instructions For Use.
  • Visually inspect ZEGALOGUE prior to administration. The solution should appear clear, colorless, and free from particles. If the solution is discolored or contains particulate matter, do not use.
  • Administer the injection in the lower abdomen, buttocks, thigh, or outer upper arm.
  • Call for emergency assistance immediately after administering the dose.
  • If there has been no response after 15 minutes, an additional dose of ZEGALOGUE may be administered while waiting for emergency assistance.
  • When the patient has responded to treatment, give oral carbohydrates to restore liver glycogen and prevent recurrence of hypoglycemia.
  • Do not attempt to reuse ZEGALOGUE. Each ZEGALOGUE device contains a single dose of dasiglucagon and cannot be reused.
  )
  
  
• If there has been no response after 15 minutes, an additional dose of ZEGALOGUE from a new device may be administered while waiting for emergency assistance. (
  
  
  
  2.1 Administration Instructions

  ZEGALOGUE autoinjector and prefilled syringe are for subcutaneous injection only.

  Instruct patients and their caregivers on the signs and symptoms of severe hypoglycemia. Because severe hypoglycemia requires the help of others to recover, instruct the patient to inform those around them about ZEGALOGUE and its Instructions For Use. Administer ZEGALOGUE as soon as possible when severe hypoglycemia is recognized.

  Instruct the patient or caregiver to read the Instructions For Use at the time they receive a prescription for ZEGALOGUE. Emphasize the following instructions to the patient or caregiver:

  • Administer ZEGALOGUE according to the printed instructions on the protective case label and the Instructions For Use.
  • Visually inspect ZEGALOGUE prior to administration. The solution should appear clear, colorless, and free from particles. If the solution is discolored or contains particulate matter, do not use.
  • Administer the injection in the lower abdomen, buttocks, thigh, or outer upper arm.
  • Call for emergency assistance immediately after administering the dose.
  • If there has been no response after 15 minutes, an additional dose of ZEGALOGUE may be administered while waiting for emergency assistance.
  • When the patient has responded to treatment, give oral carbohydrates to restore liver glycogen and prevent recurrence of hypoglycemia.
  • Do not attempt to reuse ZEGALOGUE. Each ZEGALOGUE device contains a single dose of dasiglucagon and cannot be reused.
  )
  
  
• When the patient has responded to treatment, give oral carbohydrates. (
  
  
  
  2.1 Administration Instructions

  ZEGALOGUE autoinjector and prefilled syringe are for subcutaneous injection only.

  Instruct patients and their caregivers on the signs and symptoms of severe hypoglycemia. Because severe hypoglycemia requires the help of others to recover, instruct the patient to inform those around them about ZEGALOGUE and its Instructions For Use. Administer ZEGALOGUE as soon as possible when severe hypoglycemia is recognized.

  Instruct the patient or caregiver to read the Instructions For Use at the time they receive a prescription for ZEGALOGUE. Emphasize the following instructions to the patient or caregiver:

  • Administer ZEGALOGUE according to the printed instructions on the protective case label and the Instructions For Use.
  • Visually inspect ZEGALOGUE prior to administration. The solution should appear clear, colorless, and free from particles. If the solution is discolored or contains particulate matter, do not use.
  • Administer the injection in the lower abdomen, buttocks, thigh, or outer upper arm.
  • Call for emergency assistance immediately after administering the dose.
  • If there has been no response after 15 minutes, an additional dose of ZEGALOGUE may be administered while waiting for emergency assistance.
  • When the patient has responded to treatment, give oral carbohydrates to restore liver glycogen and prevent recurrence of hypoglycemia.
  • Do not attempt to reuse ZEGALOGUE. Each ZEGALOGUE device contains a single dose of dasiglucagon and cannot be reused.
  )
  
  
• Do not attempt to reuse ZEGALOGUE. Each device contains a single dose of dasiglucagon and cannot be reused. (
  
  
  
  2.1 Administration Instructions

  ZEGALOGUE autoinjector and prefilled syringe are for subcutaneous injection only.

  Instruct patients and their caregivers on the signs and symptoms of severe hypoglycemia. Because severe hypoglycemia requires the help of others to recover, instruct the patient to inform those around them about ZEGALOGUE and its Instructions For Use. Administer ZEGALOGUE as soon as possible when severe hypoglycemia is recognized.

  Instruct the patient or caregiver to read the Instructions For Use at the time they receive a prescription for ZEGALOGUE. Emphasize the following instructions to the patient or caregiver:

  • Administer ZEGALOGUE according to the printed instructions on the protective case label and the Instructions For Use.
  • Visually inspect ZEGALOGUE prior to administration. The solution should appear clear, colorless, and free from particles. If the solution is discolored or contains particulate matter, do not use.
  • Administer the injection in the lower abdomen, buttocks, thigh, or outer upper arm.
  • Call for emergency assistance immediately after administering the dose.
  • If there has been no response after 15 minutes, an additional dose of ZEGALOGUE may be administered while waiting for emergency assistance.
  • When the patient has responded to treatment, give oral carbohydrates to restore liver glycogen and prevent recurrence of hypoglycemia.
  • Do not attempt to reuse ZEGALOGUE. Each ZEGALOGUE device contains a single dose of dasiglucagon and cannot be reused.
  )
  
  

ZEGALOGUE injection is a clear, colorless solution available as:

• 0.6 mg/0.6 mL single-dose autoinjector
• 0.6 mg/0.6 mL single-dose prefilled syringe

There are no available data on dasiglucagon use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes.

Untreated hypoglycemia in pregnancy can cause complications and may be fatal.

In animal reproduction studies, daily subcutaneous administration of dasiglucagon to pregnant rabbits and rats during the period of organogenesis did not cause adverse developmental effects at exposures 7 and 709 times the human dose of 0.6 mg based on AUC, respectively

• Substantial Increase in Blood Pressure in Patients with Pheochromocytoma:
  Contraindicated in patients with pheochromocytoma because ZEGALOGUE may stimulate the release of catecholamines from the tumor. (
  
  
  
  4 CONTRAINDICATIONS

  ZEGALOGUE is contraindicated in patients with:

  • Pheochromocytoma because of the risk of substantial increase in blood pressure
    [see Warnings and Precautions (5.1)]
  • Insulinoma because of the risk of hypoglycemia
    [see Warnings and Precautions (5.2)]

  Pheochromocytoma

  Insulinoma

  ,
  
  
  
  5.1 Substantial Increase in Blood Pressure in Patients with Pheochromocytoma

  ZEGALOGUE is contraindicated in patients with pheochromocytoma because glucagon products may stimulate the release of catecholamines from the tumor

  [see Contraindications (4)]

  . If the patient develops a substantial increase in blood pressure and a previously undiagnosed pheochromocytoma is suspected, 5 to 10 mg of phentolamine mesylate, administered intravenously, has been shown to be effective in lowering blood pressure.
  )
  
  
• Hypoglycemia in Patients with Insulinoma:
  In patients with insulinoma, administration may produce an initial increase in blood glucose, but ZEGALOGUE may stimulate exaggerated insulin release from an insulinoma and cause subsequent hypoglycemia. If a patient develops symptoms of hypoglycemia after a dose of ZEGALOGUE, give glucose orally or intravenously. (
  
  
  
  4 CONTRAINDICATIONS

  ZEGALOGUE is contraindicated in patients with:

  • Pheochromocytoma because of the risk of substantial increase in blood pressure
    [see Warnings and Precautions (5.1)]
  • Insulinoma because of the risk of hypoglycemia
    [see Warnings and Precautions (5.2)]

  Pheochromocytoma

  Insulinoma

  ,
  
  
  
  5.2 Hypoglycemia in Patients with Insulinoma

  In patients with insulinoma, administration of glucagon products may produce an initial increase in blood glucose; however, ZEGALOGUE administration may directly or indirectly (through an initial rise in blood glucose) stimulate exaggerated insulin release from an insulinoma and cause hypoglycemia. ZEGALOGUE is contraindicated in patients with insulinoma

  [see Contraindications (4)]

  . If a patient develops symptoms of hypoglycemia after a dose of ZEGALOGUE, give glucose orally or intravenously.
  )
  
  
• Hypersensitivity and Allergic Reactions:
  Allergic reactions have been reported with glucagon products and may include generalized rash, and in some cases anaphylactic shock with breathing difficulties and hypotension. (
  
  
  
  5.3 Hypersensitivity and Allergic Reactions

  Allergic reactions have been reported with glucagon products; these include generalized rash, and in some cases anaphylactic shock with breathing difficulties and hypotension. Advise patients to seek immediate medical attention if they experience any symptoms of serious hypersensitivity reactions.
  )
  
  
• Lack of Efficacy in Patients with Decreased Hepatic Glycogen:
  ZEGALOGUE is effective in treating hypoglycemia only if sufficient hepatic glycogen is present. Patients in states of starvation, with adrenal insufficiency or chronic hypoglycemia may not have adequate levels of hepatic glycogen for ZEGALOGUE to be effective. Patients with these conditions should be treated with glucose. (
  
  
  
  5.4 Lack of Efficacy in Patients with Decreased Hepatic Glycogen

  ZEGALOGUE is effective in treating hypoglycemia only if sufficient hepatic glycogen is present. Patients in states of starvation, with adrenal insufficiency or chronic hypoglycemia may not have adequate levels of hepatic glycogen for ZEGALOGUE administration to be effective. Patients with these conditions should be treated with glucose.
  )